Clinical Trials Directory

Trials / Terminated

TerminatedNCT01552993

Registration and Treatment of Pain During Eye Examination of Prematurity

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
St. Olavs Hospital · Academic / Other
Sex
All
Age
31 Weeks – 37 Weeks
Healthy volunteers
Not accepted

Summary

The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.

Detailed description

Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented. This is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol.

Conditions

Interventions

TypeNameDescription
DRUGparacetamolParacetamol mixture 20 mg/kg + pacifier and glucose
DRUGsucrosepacifier and sucrose

Timeline

Start date
2012-03-01
Primary completion
2012-10-01
Completion
2012-10-01
First posted
2012-03-13
Last updated
2016-04-22

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01552993. Inclusion in this directory is not an endorsement.